Multaq

4). Treatment with dronedarone can be initiated in an outpatient setting. Treatment with Class I or III antiarrhythmics (such as flecainide, propafenone, quinidine, disopyramide, dofetilide, sotalol, amiodarone) must be stopped before starting dronedarone.

There is limited information on the optimal timing to switch from amiodarone to dronedarone. It should be considered that amiodarone may have a long duration of action after discontinuation due to its long half-life. 1). Posology The recommended dose is 400 mg twice daily in adults.

It should be taken as: • one tablet with the morning meal and • one tablet with the evening meal. 5). 3 If a dose is missed, patients should take the next dose at the regular scheduled time and should not double the dose. Special populations Elderly Efficacy and safety were comparable in elderly patients who did not suffer from other cardiovascular diseases and younger patients.

1). 2). 4). 2). 3). 2). Paediatric population The safety and efficacy of MULTAQ in children aged below 18 years of age have not yet been established. No data are available. Method of administration Oral use. It is recommended to swallow the tablet whole with a drink of water during a meal.

The tablet cannot be divided into equal doses.

Summary of the safety profile Assessment of intrinsic factors such as gender or age on the incidence of any treatment emergent adverse reactions showed an interaction for gender (female patients) for the incidence of any adverse reactions and for serious adverse reactions.

7% in the placebo-treated group. 8% in the placebo group). The most frequent adverse reactions observed with dronedarone 400 mg twice daily in the 5 studies were diarrhoea (9%), nausea (5%) and vomiting (2%), fatigue and asthenia (7%).

Tabulated list of adverse reactions The safety profile of dronedarone 400 mg twice daily in patients with atrial fibrillation (AF) or atrial flutter (AFL) is based on 5 placebo controlled studies, in which a total of 6,285 patients were randomised (3,282 patients received dronedarone 400 mg twice daily, and 2,875 received placebo).

The mean exposure across studies was 13 months. In ATHENA study, the maximum follow-up was 30 months. Some adverse reactions were also identified during post-marketing surveillance. Adverse reactions are presented by system organ class.

Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from 11 the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

9%). This rate should be considered in the context of the underlying elevated incidence of CHF in AF patients. 4). 8% of patients receiving placebo. Cases of interstitial lung disease including pneumonitis and pulmonary fibrosis have been reported in post-marketing experience (frequency not known).

4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Careful monitoring during dronedarone administration is recommended by regular assessment of cardiac, hepatic and pulmonary function (see below). If AF reoccurs, discontinuation of dronedarone should be considered. 3. Monitoring of co-administered medicinal products like digoxin and anti-coagulants is necessary.

1). It is recommended to perform ECGs serially, at least every 6 months. If patients treated with dronedarone develop permanent AF, treatment with dronedarone should be discontinued. 3). Patients should be carefully evaluated for symptoms of Congestive Heart Failure.

There have been spontaneously reported events of new or worsening heart failure during treatment with dronedarone. Patients should be advised to consult a physician if they develop or experience signs or symptoms of heart failure, such as weight gain, dependent oedema, or increased dyspnoea.

If heart failure develops, treatment with dronedarone should be discontinued. Patients should be followed for the development of left ventricular systolic dysfunction during treatment. If left ventricular systolic dysfunction develops, treatment with dronedarone should be discontinued.

Patients with coronary artery disease In patients with coronary artery disease, clinical signs of heart failure and ECG should be regularly monitored to detect early signs of heart failure. In ESC and ACC/AHA/HRS guidelines dronedarone has a class IA recommendation in patients with paroxysmal/persistent AF and coronary artery disease.

1). Women of child bearing potential and pregnancy Dronedarone is not recommended during pregnancy and in women of childbearing potential not using contraception. Women of childbearing potential should use effective methods of contraception during treatment with dronedarone and for 7 days after the final dose.

6). Liver injury Hepatocellular liver injury, including life-threatening acute liver failure, has been reported in patients treated with dronedarone in the post-marketing setting. Liver function tests should be performed prior to initiation of treatment with dronedarone, after one week and after one month following initiation of treatment and then repeated monthly for six months, at months 9 and 12, and periodically thereafter.

5) • QTc Bazett interval ≥500 milliseconds • Severe hepatic impairment • Severe renal impairment (CrCl <30 ml/min) • Co-administration with dabigatran 4